The foreskin of a penis is an excess of skin, located proximate to the distal end of the penis, also referred to as the prepuce. The foreskin substantially covers the head of the penis, also known as the glans of the penis, the glans penis or simply the glans. Circumcision is a surgical operation in which either a portion or all the foreskin of the penis is removed. Male circumcision is one of the most common surgical procedures in the world and has been performed for ritualistic as well as hygienic reasons since ancient times. Nowadays, it may be performed for clinical reasons or to comply with religious or cultural practices (also known as non-therapeutic circumcision). Non-therapeutic circumcisions are generally performed in a religious or cultural community by general practitioners and non-clinicians. Approximately a third of human males worldwide receive a circumcision at some point in their lives. Circumcision has traditionally been performed either immediately after birth, during childhood, during adolescence or occasionally on young adults (i.e., after the teenage years).
The human immunodeficiency virus (herein abbreviated HIV) is a virus which causes AIDS, a deadly disease which has claimed more than 25 million lives worldwide since its discovery in 1981. Approximately 2 million people worldwide are infected with HIV every year, wherein roughly two thirds of those infected with HIV live in Sub-Saharan Africa. More than 1 million deaths per year occur worldwide as a result of AIDS. Various worldwide attempts to reduce infection and spreading rates of HIV, for example through massive safer sex education programs and free condom distribution points, have not significantly reduced infection rates and can be considered partially successful in reducing the spread of HIV worldwide. Prior art randomized controlled studies as well as epidemiological studies have shown that circumcision can significantly reduce the risk of infection with HIV in males. One possible explanation of the results of such studies is that the skin cells of which the foreskin is constructed have less protection to diseases and infections than skin cells on other parts of the body. Thus, the skin cells of the foreskin are more prone to diseases and infections which may be transmitted by sexual relations when the foreskin is stretched and its skin cells are revealed.
Based on these studies, the World Health Organization (known as the WHO) and the Joint United Nations Programme on HIV/AIDS (known as UNAIDS) have published position papers substantially recommending large scale circumcision of adult males worldwide living in regions and amongst populations having higher rates of HIV infection, i.e., HIV at risk regions and populations. These position papers include “Male circumcision: Global trends and determinants of prevalence, safety and acceptability,” published by the WHO and UNAIDS in 2007, ISBN 978 92 4 159616 9 (WHO), and “Male Circumcision and HIV Prevention: Research Implications for Policy and Programming—Conclusions and Recommendations,” a WHO/UNAIDS Technical Consultation presented in Montreux, Switzerland, on Mar. 6-8, 2007. In addition, other large governmental bodies have put forth possible biological explanations linking circumcision to reduction in HIV infection rate. One such biological explanation can be found on the website of the U.S.'s Centers for Disease Control and Prevention, at http://www.cdc.gov/hiv/resources/factsheets/circumcision.htm. In particular, the published papers of the WHO and the UNAIDS cited research which showed that the risk for infection of HIV is lowered by 44%-71% in circumcised men. The WHO has thus recommended circumcision to be incorporated among the main strategic tools countries and healthcare authorities should consider in order to reduce the spread of HIV.
One traditional method for performing circumcision is by surgically removing the foreskin after physically pulling the foreskin over the glans. In such methods, the foreskin is removed while it is still a live tissue, usually causing bleeding. In some cases, due to religious considerations, blood may be drawn even if bleeding does not occur. Such methods may involve hemorrhaging and a relatively long period of healing of the incision (e.g., up to a few weeks), while inducing sustainable pain in an individual. In most cases suturing is required when such a procedure is performed on adult males. Such methods, referred to also as a mini-surgery, can incur substantial costs on an individual undergoing such a procedure as well as on organizations conducting circumcisions on a large scale (such as national public health ministries). In addition, when the above mentioned circumcision procedure is performed on a large scale (i.e., for a large number of individuals such as thousands of individuals), such mini-surgeries may require many resources, including trained surgical personnel, a clean and sterile surgery environment as well as the availability and administration of local anesthesia. Otherwise, serious side effects may be incurred on individuals undergoing such procedures. In general, such methods are recognized as not being scalable for mass circumcision campaigns, in particular in areas where medical facilities may be sparse or not available and where skilled personnel is scarce. It is therefore desirable to have a circumcision device that is scalable for mass circumcision and is also associated with as little pain as possible since perceptions of pain will substantially reduce the willingness (also known as the compliance level) of males to undergo circumcision.
Other methods and devices for performing circumcision are known in the art. Such methods may require anesthesia, sutures, skilled personnel, may not be bloodless and may not be scalable for mass circumcision campaigns. One such method for performing a circumcision is shown on the website http://www.circ-ring.de/us/circ ring english.html (owned by the company Circ-Ring International and known commercially as the Zhenxi Ring), which discloses a device for performing a circumcision by applying the foreskin to a ring, and then clutching the foreskin with a tight fastening portion. Other variants of this method are known and are described below. In such a manner, the foreskin is tightly compressed and blood is prevented from flowing therein. The fastening portion is an enclosing clamp fastened by a screw portion. Excess skin (i.e., the foreskin) is removed using a scalpel or another sharp implement. As the foreskin is tightly compressed when the ring is placed around the penis, a local anesthesia is substantially required when the fastening portion is fastened and tightened around the penis to reduce any feelings of pain the individual may experience in his penis while the device is placed on his penis. As the ring fits securely around the penis in a flaccid state, pain may be experienced by the individual during an erection, such as erections which may occur during sleep.
A similar device to the Zhenxi Ring is disclosed in PCT International Publication No. WO 2007/022730A1 (also known commercially as the ShangRing and available on the website www.snnda.com). The compression mechanism of this device as well as the cutting of the excess skin when it is deployed on a penis are likely to make the removal process of the device painful, typically requiring the application of local anesthesia during placement of and removal of the device, as well as other additional procedures such as soaking the area adjacent to the device in iodine prior to removal of the device. In addition, use of this device, which includes an inner ring, may involve pain while the device is on an individual's penis, such as during erections occurring in the individual while the individual is asleep. Pain associated with use of the ShangRing as well as mechanisms for dealing with such pain are discussed in the following journal articles: “Clinical application of a new device for minimally invasive circumcision” to Peng et al., published in the Asian Journal of Andrology 2008, 10(3), pp. 447-454 and “Adult Male Circumcision Using the Chinese Shang Ring: Results of 328 Cases and a Recommended Standard Surgical Protocol in China” to Cheng et al., published in the National Journal of Andrology (China) July 2009, 15(7), pp. 584-592. The Peng article suggests prescribing medication having anti-libido attributes, such as oral diethylstilbestrol, to prevent erections while an individual is asleep. The Cheng article suggests making small incisions along the edge of the foreskin on the underside of the ring to minimize pain during nocturnal erections. Such incisions could increase the risk of infection in live skin tissue. Both suggestions just mentioned involve pain and possible risks related to the ring being too tight in certain circumstances. In addition, part of the procedure of using the ring involves making incisions in tissue that is not dead. Such incisions may involve an amount of bleeding and could potentially lead to infections.
U.S. Pat. No. 4,491,136 issued to LeVeen and entitled “Disposable Circumcision Device,” is directed to a device for performing circumcision. The device includes a male and a female member. The male member is a tubular support having an annular groove. The female member is a clamp or an elastic ring, adapted to fit over the annular groove. The foreskin is stretched over the male member. The female member is then applied over the annular groove, compressing the foreskin along the groove. This action traps the foreskin between the two members. The excess foreskin is then cut off and the male member is removed from beneath the ring of the female member, forcing the cut end of the foreskin to be prevented from bleeding. After the ends of the foreskin have healed, the female member and rings are removed in a few days time. The device of LeVeen enables the ends of the foreskin to heal after the excess foreskin is cut off, which reduces the need for suturing. At the same time, this device still involves a surgical procedure of excising the foreskin while it is still a live tissue. In addition, the mechanism of trapping the foreskin between the two members does not enable natural detachment of the foreskin, thereby possibly causing pain to the individual while the device is deployed, used and then removed.
U.S. Pat. No. 5,269,788 issued to Nelson, III, and entitled “Adjustable Hemostatic Circumcision Dressing and Method of its Use,” is directed to a device for performing circumcision. The device includes an inner arcuate member having a pair of ends, an elongated hollow connector piece and an outer arcuate grooved member. The inner member is positioned between the prepuce and shaft of a penis parallel to the corona of the glans of the penis. The hollow connector piece receives the pair of ends of the inner member. The outer arcuate grooved member is positioned over and encompasses the prepuce (i.e., foreskin), when it is pulled up over the inner member. The groove is disposed about the inner periphery of the outer member. The inner member press-fits into the outer member groove when the members are brought into mating relationship, with the foreskin held there between. A crushing action is thereby exerted upon the foreskin, causing hemostasis. After the application of the outer member, the foreskin is excised with a sharp instrument such as a scalpel or scissors or with a surgical cautery. The inner and outer members, securely in position, act as both a line of sutures and a sterile dressing for the circumcision. Between the members, pressure necrosis and healing occur in the course of approximately two to three weeks. On a return visit to a physician, the outer and inner members are removed to reveal the healed circumcision. The device of Nelson, III, requires a surgical removal of the foreskin at the time the device is deployed. In general, an individual may feel pain when such a device is used unless anesthesia is applied to the area of the penis surrounding the foreskin. In addition, this device requires a sterile environment as well as surgical tools to excise the foreskin at the time the device is deployed. As the foreskin in this device is excised while still a live tissue, an increased risk is involved in healthy skin tissue being incorrectly excised.
U.S. Pat. No. 7,303,567 issued to Smith, and entitled “Circumcision Device,” is directed to a device for performing a circumcision. The device includes a ring, a bridge and a handle. The ring has a tapered interior surface, an open anterior end, an anterior opening defined by the interior surface at the anterior end, an open posterior end and a posterior opening defined by the interior surface at the posterior end. The posterior opening is larger than the anterior opening. The ring also includes an exterior surface and a groove circumferentially defined around the exterior surface adjacent to the anterior end. The bridge extends over the anterior opening and is fixedly connected to the anterior end at circumferentially spaced points thereof. The handle is fixedly but frangibly connected to the bridge at a junction between the handle and the bridge. The handle extends longitudinally and outwardly from the junction, being structurally weaker adjacent to the junction than to any other portion of the handle. The handle is thus readily breakable and detachable from the bridge at the junction.
To use the device, a surgeon grasps the handle of the circumcision device and positions the ring over the glans. The foreskin is pulled distally over the ring, followed by the tying of a ligature around the foreskin so as to compress the foreskin into the groove of the ring. Excess foreskin distal to the ligature and adjacent to the anterior end of the ring is trimmed off with scissors or a scalpel. Finally, the handle is broken off and detached from the bridge, leaving the bridge connected to the ring and the flange. The glans now partially protrudes from the anterior end so that its tip is in contact with the inner surface of the bridge. The bridge therefore acts as an obstruction to the glans, thereby limiting its protrusion from anterior end. Protrusion is sufficiently limited so that after 3-8 days, the ring and attached bridge are allowed to fall off the penis once the foreskin under the ligature dies. As described above in other prior art devices, the device of Smith requires the foreskin to be excised when the device is used. In addition, the nature of the mechanism of Smith may make it impractical for large scale use, possibly causing reluctance among males to undergo the procedure of circumcision.
Other patents and patent applications for methods and devices for performing a circumcision include Chinese (CN) Patent Application Publication No. 101327144A, Chinese (CN) Patent No. 2048737 and U.S. Pat. Nos. 2,272,072, 2,561,176 and 5,649,933.